Systems and methods for maintaining a narrow body lumen

ABSTRACT

Devices and processes for maintaining a narrow body lumen are described. One embodiment of the inventive device includes: (i) a hydraulic propulsion mechanism for propelling an imaging portion or a therapeutic portion through the narrow body lumen; and (ii) a retrieval mechanism for retrieving the imaging portion or the therapeutic portion from the narrow body lumen.

RELATED APPLICATION

The application is a continuation of, and claims the benefit of priorityto, U.S. patent application Ser. No. 14/929,989, filed Nov. 2, 2015,which is a divisional of U.S. patent application Ser. No. 13/979,691,filed Jul. 15, 2013, now granted as U.S. Pat. No. 9,173,571, which is aNational Stage Entry of PCT Application Serial No. PCT/US2012/022619,filed Jan. 25, 2012, which claims the benefit of priority under 35U.S.C. § 119 to U.S. Provisional Application Ser. No. 61/435,945, filedJan. 25, 2011, the disclosures of which are herein incorporated hereinby reference in their entirety.

FIELD OF THE INVENTION

The present invention relates generally to maintenance of a narrow bodylumen. More particularly, the present invention relates to systems ormethods for diagnostic imaging or therapeutic treatment to effectivelymaintain the narrow body lumen.

BACKGROUND OF THE INVENTION

For a variety of reasons, occlusions often develop in narrow body lumens(i.e., the channel of a tubular-shaped anatomical structure, such as thefallopian tubes, intestines, and coronary arteries) and havemedically-relevant consequences on the body. Conventional techniquesemployed to maintain the health of fallopian tubes, as an example of anarrow body lumen, are described below.

Fallopian tubes are vessel-like, non-fluid filled structures that extendfrom the uterus to the ovaries. On average, fallopian tubes measurebetween eight and ten centimeters in length. The inner diameter of thetube varies significantly depending on the segment of the tube, with aminimum inner diameter of approximately one millimeter and a maximum ofsix millimeters. Along the length of the lumen of the fallopian tubemillions of microscopic hair-like cilia pulsate in wave-like motions atthe rate of hundreds of times per second. This motion assists the egg,delivered from the ovaries during ovulation, in passing through the tubeto the uterine cavity. Cells located in the tube's inner lining(endothelium) supply the egg with vital nourishment and providelubrication along the path. It is within the fallopian tube that thesperm first contacts the egg. If the egg is not fertilized withintwenty-four to thirty-six hours of reaching the fallopian tube, the eggdeteriorates and is removed from the tube by the body's immune system.

Disease of fallopian tube often presents as occlusion or thickening ofthe fallopian tube wall and can be caused by infection as well asscarring. In particular, pelvic inflammatory disease (PID), urinarytract infections (UTI) as well as sexually transmitted infections (STI)may cause severe inflammation that in turn blocks the tube.Endometriosis may also cause occlusion when the uterine lining growsinto the fallopian tube. An appendectomy or other abdominal surgery mayfurther similarly lead to occluded fallopian tubes. Regardless of themanner in which it is formed, an occlusion can lead to a hydrosalpinx,where the tube increases in diameter because it is filled with fluid.The presence of fluid prevents both the egg and sperm from travelingthrough the fallopian tube, preventing fertilization. It is believedthat hydrosalpinx can reduce the success rate of in-vitro fertilizationby up to 8%.

In the US alone, there are at least seven million cases of infertilityannually and an estimated 25-40% of these cases are caused by fallopiantube occlusion or disease. Hysterosalpingogram (HSG), a procedure mostcommonly utilized to diagnose fallopian tube disease, requires aradiologist to inject dye into the uterus under x-ray guidance. The dyeenters the fallopian tube through the ostia (openings) located in theuterus. If a woman's fallopian tubes are patent (open), dye will flowinto the peritoneal cavity. In order to visualize the fluid path, aseries of timed x-rays are taken.

Unfortunately, this procedure suffers from several drawbacks. By way ofexample, HSG suffers from a high false negative rate of 30% and a highfalse positive rate of 40% due to tubal spasms or shadow (noise) in thex-rays. This often necessitates further procedures. This high rate ofinaccuracy is also partly due to the fact that radiologists are not asintimate with the tortuosity and topography of the fallopian tube asgynecologist or reproductive endocrinologist.

As another example of a drawback, HSG is not conducted in-office by agynecologist or reproductive endocrinologist, the primary caretaker ofthe patient, as it necessitates a substantial investment in x-raycapital equipment mostly found in hospitals. The patient typically firstvisits a gynecologist, who conducts a series of blood tests anddetermines whether HSG is necessary. If it is deemed necessary, then thepatient schedules an appointment with the radiologist to have the HSGprocedure administered. At the conclusion of the first procedure, thepatient returns either to the gynecologist or reproductiveendocrinologist to discuss the results. Because of the high inaccuracyrate associated with the HSG, the patient often returns to theradiologist for a second procedure, creating additional unnecessarycosts for both the patient and hospital.

As yet another example, patients often complain of pain and some areallergic to the dye used during the procedure. Furthermore, HSG must beconducted before day 12 of a woman's menstrual cycle because the dye mayharm a potential full term pregnancy, which limits options for bothdoctor and patient and further extends the waiting period for a fullinfertility diagnosis, which is emotionally taxing to the patient andfamily.

To overcome these drawbacks, different direct visualization techniqueshave been attempted. FIG. 1 shows an endoscope, which uses conventionaloptical fiber imaging technology, as an exemplar attempt to achievedirect visualization of the fallopian tubes. In this figure, a femalereproductive anatomy 10 undergoing imaging includes fallopian tubes 12,ovaries 14, uterus 16, uterine cavity 22, cervix 28 and fimbria 30. Animaging catheter shaft 20 is introduced into a fallopian tube, which hasa consistency of a wet paper towel. Catheter shaft 20 passes throughfallopian tube ostia in the uterus 18, beyond which point the fallopiantube 12 is narrow and tortuous.

Unfortunately, the wet-paper-towel consistency does not provide adequatetactile feedback to a physician, who navigates catheter 20 throughfallopian tube 12. As a result, during the imaging procedure, thephysician is not aware of the undue pressure exerted against thefallopian tube, leading to perforation 24. To this end, FIG. 1 shows aportion of catheter 26 protruding out of perforation 24 in fallopiantubes 12. Perforation of the fallopian tube may prevent eggs from theovaries 14 of the patient from reaching the uterus 16 for fertilization,making perforation an unacceptable clinical adverse event in a patientwho is actively attempting to conceive. In addition to running the riskof perforating the fallopian tubes, the imaging procedure describedabove involves several steps and is therefore viewed by physicians asconvoluted and difficult to perform correctly. Furthermore, the wetpaper towel consistency of the fallopian tubes prevents the attemptedimaging procedure from obtaining a clear, focused image. Specifically,during imaging, the wet paper towel consistency causes the fallopiantubes' walls to “fold” over the endoscope's tip, making it difficult tomaintain a sufficient distance between the endoscope's tip and the wallsof the fallopian tubes to focus and take a clear picture.

Therefore, what is needed is a novel diagnostic and therapeutic systemand method which allows for effective maintenance of a narrow bodylumen, without suffering from the drawbacks encountered by the currentand attempted systems and methods described above.

SUMMARY OF THE INVENTION

In view of the foregoing, in one aspect, the present invention providesa device for maintaining a narrow body lumen (e.g., the channel of atubular-shaped anatomical structure, such as the fallopian tubes,intestines, and coronary arteries). The device includes: (i) a hydraulicpropulsion mechanism for propelling an imaging portion or a therapeuticportion through the narrow body lumen; and (ii) a retrieval mechanismfor retrieving the imaging portion or the therapeutic portion from thenarrow body lumen.

In one embodiment of the present invention, the device further includesa handle portion, which receives one or more luers, one of which isdesigned to provide hydraulic pressure to hydraulically propel theimaging portion or the therapeutic portion through the narrow bodylumen. The luer is preferably designed to receive a hydraulic propellantfrom a reservoir containing the hydraulic propellant.

The device may further include a wire luer, which is received by thehandle portion and is designed to provide a wire for conveyingelectrical power and signals to facilitate an imaging function carriedout by the imaging portion.

The device may further still include a seal-creating lure, which isreceived by the handle portion and is designed to create a seal tofacilitate imaging or therapeutic treatment. In certain embodiments ofthe present invention, an inflatable object is used for creating a sealto facilitate imaging or therapeutic treatment. In these embodiments,the seal-creating lure may also be referred to as an inflation luer asit facilitates inflation of the inflatable body.

In another aspect, the present invention provides a narrow body lumendiagnostic device. The device includes: (i) a guide wire capable ofproviding light or sensing an image and for guiding a catheter to atarget location, the guide wires including illuminating fibers orimaging fibers; and (ii) a catheter including imaging fibers if theguide wire includes illuminating fibers or the catheter includingilluminating fibers if the guide wire includes imaging fibers.

In yet another aspect, the present invention provides a fallopian tubediagnostic device. The device includes: (i) a sensing lumen forproviding a catheter including a sensing portion and an inflatableportion, and the sensing portion capable of sensing information aboutthe fallopian tube; (ii) a solution lumen for providing a solution whichfacilitates sensing carried out by the sensing portion; and (iii)wherein, in an operational state of the fallopian tube diagnosticdevice, the inflatable portion inflates to create a space around thesensing portion such that in presence of the solution, the sensingportion senses information regarding the fallopian tube. In certainpreferred embodiments of the present invention, the device includes atherapeutic lumen to provide therapy to a localized region in thefallopian tube.

In yet another aspect, the present invention provides a process ofmaintaining a narrow body lumen. The process includes: (i) creating aseal inside or outside the narrow body lumen such that in presence of ahydraulic propellant, the narrow body lumen is pressurized to allowdiagnostic imaging of the narrow body lumen using an imaging portion ofan imaging device; (ii) hydraulically propelling, using the hydraulicpropellant, the imaging portion through the narrow body lumen; (iii)imaging the narrow body lumen; and (iv) retrieving the imaging portionfrom the narrow body lumen.

In a preferred embodiment of the present invention, the above-describedprocess includes: (i) establishing a channel from outside the narrowbody lumen to a proximal region of the narrow body lumen or a regionthat is proximate to the narrow body lumen; (ii) placing the imagingportion through the channel; and (iii) wherein the placing is carriedout before the creating.

In yet another aspect, the present invention provides a process formaintaining a narrow body lumen. The process includes: (i) sealing thenarrow body lumen to allow therapeutic treatment of the narrow bodylumen using a therapeutic device; (ii) hydraulically propelling thetherapeutic device through the narrow body lumen; (iii) treating thenarrow body lumen; and (iv) retrieving the therapeutic device from thenarrow body lumen.

The process may further include: (i) defining a channel from outside thenarrow body lumen to a proximal region of the narrow body lumen or aregion that is proximate to the narrow body lumen; (ii) placing thetherapeutic device through the channel; and (iii) wherein the placing iscarried out before the sealing.

In yet another aspect, the present invention provides a process ofmaintaining a fallopian tube. The process includes: (i) steering a guidewire through a channel to a target location within a fallopian tube andthe guide wire capable of providing light or imaging; (ii) placing overthe guidewire a catheter for providing light or imaging; (iii) imagingor illuminating the fallopian tube using the guide wire and thecatheter; and (iv) retrieving the catheter from the fallopian tube.

The process may further includes: (i) removing the guidewire from aguidewire lumen; and (ii) introducing a therapy or a saline flushthrough the guidewire lumen.

The construction and method of operation of the invention, however,together with additional objects and advantages thereof, will be bestunderstood from the following descriptions of specific embodiments whenread in connection with the accompanying figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an endoscope being navigated through the fallopian tubesand major organs of a female reproductive system.

FIG. 2 shows a side-sectional view of a diagnostic device, according toone embodiment of the present invention, in a non-operational state.

FIG. 2A shows a magnified view of a distal tip of a shaft portion of thediagnostic device shown in FIG. 2.

FIG. 2B shows a side-sectional view of a distal tip of a shaft portionof a therapeutic device, according to one embodiment of the presentinvention.

FIG. 3 shows a side-sectional view of a shaft portion, according toanother embodiment of the present invention, in an operational state ofthe diagnostic device of FIG. 2.

FIG. 4A is a perspective view of two different ovular-shaped distaltips, according to certain embodiments of the present invention, used ina guidewire-based diagnostic imaging device or in a guidewirelumen-based therapeutic intervention device.

FIG. 4B is a top view of the distal tip shown in FIG. 4A.

FIG. 5A is a perspective view of a conical-shaped distal tip, accordingto one embodiment of the present invention, used in a guidewire-baseddiagnostic imaging device or in a guidewire lumen-based therapeuticintervention device.

FIG. 5B is a top view of the distal tip shown in FIG. 5A.

FIG. 6A is a side view of a non-inflated conical-shaped distal tip,according to one embodiment of the present invention, used in anon-guidewire-based diagnostic imaging device or in a non-guidewirelumen-based therapeutic intervention device.

FIG. 6B is a side view of the conical-shaped distal tip of FIG. 6A inits inflated state.

FIG. 7A is a side view of a non-inflated ovular-shaped distal tip,according to one embodiment of the present invention, used in anon-guidewire-based diagnostic imaging device or in a non-guidewirelumen-based therapeutic intervention device.

FIG. 7B is a side view of the ovular-shaped distal tip of FIG. 7A in itsinflated state.

FIG. 8A is a side view of a non-inflated dome-shaped distal tip,according to one embodiment of the present invention, used in anon-guidewire-based diagnostic imaging device or in a non-guidewirelumen-based therapeutic intervention device.

FIG. 8B is a side view of the dome-shaped distal tip of FIG. 8A in itsinflated state.

FIG. 8C shows certain major components, according to one embodiment ofthe present invention, in the distal tip as shown in FIG. 8B.

FIG. 9 shows a process flow diagram, according to one embodiment of thepresent invention that uses a hydraulic propulsion mechanism fordiagnostic imaging.

FIG. 10 shows a process flow diagram, according to one embodiment of thepresent invention that uses a guide wire mechanism for diagnosticimaging.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

In the following description, numerous specific details are set forth inorder to provide a thorough understanding of the present invention. Itwill be apparent, however, to one skilled in the art that the presentinvention may be practiced without limitation to some or all of thesespecific details. In other instances, well-known process steps have notbeen described in detail in order to not unnecessarily obscure theinvention.

In certain embodiments, the present invention provides novel systems andmethods for accurate real time-visualization, which dynamically diagnosemalfunction of the fallopian tubes. In preferred embodiments of thepresent invention, a single-use, disposable product and its associatedprocedure overcomes the many drawbacks encountered with current andattempted diagnostic approaches. The present inventions' more accurate,dynamic procedure may be conducted in an office of a gynecologist or areproductive endocrinologist, who is typically the first and main pointof contact for an infertility patient, understands the anatomy inquestion, and is better trained to dynamically change or repeat steps inthe procedure if further clarification is needed. As a result, thenumber of office visits and costs to both the patient and hospital aresignificantly reduced, and at the same time, convenience to the partiesinvolved is significantly increased. Furthermore, the high falsepositive rate of 20% to 40% encountered by the conventional diagnosticsystems and procedures is also reduced by the present inventions'ability to directly visualize the fallopian tubes.

Preferred embodiments of the present invention recognize that to carryout certain initial steps of the inventive procedures, conventionaldiagnostic procedures may be relied upon to an extent. By way ofexample, certain inventive procedures require visualization of theopenings (ostia) of the fallopian tubes in the uterus so that the tubesmay be accessed. Those skilled in the art will recognize that althoughconventional hysteroscopes were primarily used to evaluate and maintainthe health of a uterus, due to recent advancements in less invasivesterilization procedures such as Es sure and Adiana (during which thetube is purposely occluded), a large numbers (e.g., up to 7,500 for theEssure alone) of gynecologists and reproductive endocrinologists haveadopted the hysteroscopes to visualize, and trans-vaginally access, thefallopian tube. The present invention proposes to use the hysteroscope'sworking channel, in certain embodiment of the present invention. Oncegynecologists or reproductive endocrinologists own or lease ahysteroscope (and the associated capital equipment), they are free touse the inventive procedures of the present invention using the workingchannel of the hysteroscope because they are unlimited in terms of whichprocedures they may conduct using their hysteroscope. It is noteworthythat the working channel of any catheter, which can visualize and gainaccess to the ostia of the fallopian tubes within the uterus, may beutilized by the present invention.

In preferred embodiments of the present invention, navigating asubstantially transparent capsule, which houses a camera portion throughthe tortuous and narrow fallopian tubes by using a hydraulic propulsionmethod, has several advantages over navigating a purely catheter-basedproduct through the fallopian tubes. By way of example, hydraulicpropulsion overcomes the clinical adverse event of perforation, adrawback of previous direct visualization technologies. In otherpreferred embodiments of the present invention, hydraulic propulsionavoids perforation as the device does not depend on the tactile feedbackof the fallopian tube. Instead, the hydraulic propellant carries thecamera portion through the natural path of the fallopian tube.

In accordance with one embodiment, the present invention provides ahydraulic propulsion device that uses a working channel of ahysteroscope to access the ostia of the fallopian tubes. To this end,FIG. 2 shows a hydraulic propulsion device 100 having a handle portion102, a shaft portion 104, and a seal-creating portion 106. As shown inFIG. 2A, which shows a magnified view of a tip of hydraulic propulsiondevice 100, device 100 includes an imaging subassembly 108 and a capsule110.

Referring back to FIG. 2, handle portion 102 may come equipped with ahydraulic pressure port 112, which is designed to receive a hydraulicpropellant (e.g., a saline solution) from a hydraulic propellantreservoir, such as a syringe. Hydraulic pressure port 112 is preferablycommunicatively coupled to a hydraulic pressure lumen (not shown tosimplify illustration) which extends from handle portion 102 throughshaft portion 104 to a location near imaging subassembly 108.

Similarly, an electrical wire 118 runs from handle portion 102 throughshaft portion 104 and is communicatively coupled to imaging subassembly108. Electrical wire 118 enters a handle portion at an electrical accessport 114, which connects to a wire lumen. Electrical wire 118 is placedinside the wire lumen, which also extends from handle portion 102through shaft portion 104 to a location near image subassembly 108.

A seal-creating port 116 of FIG. 2 facilitates a step of creating a sealat an ostia 18 of the fallopian tubes 12 or inside the proximal regionof the fallopian tubes. These anatomies are shown in FIG. 1.Specifically, seal-creating port 116 of FIG. 2 is communicativelycoupled to a seal-creating lumen (not shown to simplify illustration),which transports the necessary materials for creating a seal toseal-creating portion 106. In preferred embodiments, seal-creatingportion 106 of the present invention is an inflatable body and theseal-creating port 116 is an inflatable port. In these embodiments, theseal-creating lumen is designed to convey air or other gas that inflatesthe inflatable body and the seal-creating lumen may be referred to asthe “inflation lumen.”

In addition to one or more of the ports and lumens described above,handle portion 102 preferably includes a housing 120 for holding inplace coiled wire 118′, and a wire retrieval mechanism 122 to retrieve ahydraulically propelled wire in an operational state of device 100(which is shown as device 200 in FIG. 3). Not all features of housing120 are shown to simplify illustration and those skilled in the art willrecognize that wire retrieval mechanism 122, in a preferred embodimentof the present invention, is akin to a fishing rod, which has a reelmechanism for casting and retrieving a fishing line. In this embodiment,retrieval mechanism 122 includes flexible wire 118 and a reel capable ofreeling back the flexible wire from a propelled state. During anoperational state of device 100, when the reel is activated, imagingsubassembly 108 is retrieved back from a propelled state, preferablyinto handle portion 102.

In a more preferred embodiment of the present invention, retrievalmechanism 122 includes an electronically activated reel, whichelectronically activates retrieval of the reel from the propelled stateof the reel. In this embodiment, inventive devices include a pressuresensor for conveying a pressure measurement to the electricallyactivating reel mechanism such that if the pressure exceeds apredetermined value of pressure, then the electrically activating reelmechanism ceases to retrieve imaging subassembly 108. The pressuresensor may be designed to sense the pressure exerted on imagingsubassembly 108, as it is retrieved from the narrow body lumen.

As part of shaft portion 104, seal-creating portion 106 (e.g.,inflatable body) is located outside and distal to handle portion 102. Inthis configuration and when device 100 is in an operational state,imaging portion 108 forms a perfect seal with an inner diameter of thehydraulic propellant lumen, as shown in FIG. 2A. As is explained laterin connection with FIG. 3, this seal allows for hydraulic propulsion ofimaging portion 108. In other preferred embodiments of the presentinvention, device 100 includes a locking mechanism, which locks imagingportion 108 within the inner diameter of the hydraulic propellant lumenuntil a requisite pressure is achieved to enable hydraulic propulsion.

Image subassembly 108 preferably includes an image sensor and a lightsource. The image sensor can be any object that is capable of sensing animage. In a preferred embodiment of the present invention, the imagesensor includes at least one member selected from a group consisting ofa charge coupled device (CCD), a complementary metal oxide semiconductor(CMOS) and an optical fiber. The light source includes a fiber opticslight source or a light emitting diode (“LED”).

In certain embodiments of the present invention, an inflatable objectcontains the image sensor and the lighting source such that when theinflatable body is inflated, the imaging sensor is positioned near or atan approximate focal length away from the narrow body lumen to allowfocused imaging of the narrow body lumen. In this embodiment, the focallength is associated with the imaging sensor. If the image sensor is acamera, then the focal length referred to herein is that of the camera.

As shown clearly in FIG. 2A, capsule 110 protects a portion of imagingsubassembly 108. In one embodiment of the present invention, capsule 110is coated with a lubricant to facilitate hydraulic propulsion orretrieval of the capsule through the narrow body lumen. Capsule 110preferably encapsulates a wireless transmitter for wirelesslytransmitting images captured by an imaging sensor of imaging subassembly108. In certain preferred embodiments, capsule 110 of the presentinvention encapsulates a pressure sensor, which senses an amount ofpressure being applied against the narrow body lumen to determinepresence of blockages within the narrow body lumen.

Capsule 110 is substantially round and therefore avoids causing tissuetrauma, which is a drawback of previously attempted direct visualizationdevices. Furthermore, capsule 110 has centered within it imaging portion108. The positioning of imaging portion 108 within capsule 110 overcomesthe drawback of the fallopian tube hanging over the distal end of thecatheter, preventing an inadequate focal length and therefore unclearpicture from being taken.

In one embodiment of the present invention, the capsule is designed forencapsulating an inflatable body to enhance buoyancy of a portion ofimaging subassembly 108 that is deployed inside the narrow body lumenduring hydraulic propulsion. In such embodiments, capsule 110 of thepresent invention facilitates hydraulic propulsion of the propelledimaging portion as the inflatable body makes the capsule more easiercarried by the hydraulic propellant.

In certain embodiments of the present invention, capsule 110encapsulates a microgenerator, which uses the hydraulic propellant toprovide power for the light source or the imaging sensor. In thisembodiment, the microgenerator of the present invention convertshydraulic energy into electrical energy. This electrical energy is thenused to power imaging portion 108 of the device. In other embodiments ofthe present invention, capsule 110 encapsulates optical fibers, whichfacilitate imaging by sending imaging signals from within the capsule tothe imaging sensor that is located outside capsule 110 and distal tohandle portion 102.

FIG. 2B shows a tip of device 100, according to an alternate embodimentof the present invention, where an optical fiber 111 is used forimaging. In this embodiment, optical fiber 111, during an operationalstate of device 100, conveys the image signals captured to an imagesensor located outside and proximal to shaft 104 of device 100. Asstandard off the shelf optical fibers may be found having outerdiameters of less than 0.5 mm, the diameter of capsule 110 of thisembodiment may be reduced as it does not contain the sensor. As aresult, the tip of this embodiment is more easily navigated through thenarrow and tortuous path of the fallopian tubes and using optical fiber111 represents an alternative embodiment of the present invention.

FIG. 3 shows a portion of device 200 (which is the operational state ofdevice 100), according to one embodiment of the present invention.Device 200 includes a flexible wire 218, a fallopian tube-access device228, a shaft portion 204, a seal-creating portion 206, an imagingsubassembly 208 and capsule 210. Wire 218, shaft portion 204,seal-creating portion 206, imaging subassembly 208 and capsule 210 aresubstantially similar to their counterparts (i.e., wire 118, shaftportion 104, seal-creating portion 106, imaging subassembly 108 andcapsule 110) shown in FIG. 1, except device 200 shows imagingsubassembly 208 and capsule 210 being hydraulically propelled during anoperational state of device 200. In one preferred embodiment of thepresent invention, device 200 includes a sail, which surrounds imagingsubassembly 208, such that when the imaging subassembly is hydraulicallypropelled, the sails expand to enhance the hydraulic propulsion of theimaging subassembly.

Although in connection with FIGS. 2, 2A, 2B and 3, hydraulic propulsionis described to propel imaging subassembly 108, imaging optical fiber111 or capsule 110, other preferred embodiments of the present inventioncontemplate hydraulically propelling therapy into the narrow body lumen.In this embodiment, imaging subassembly 108, imaging optical fiber 111or capsule 110 are absent and electrical access port 114 is replaced bya therapy port. Furthermore, the therapy port is communicatively coupledto a therapy lumen, which replaces the wire lumen. Effective therapiescontemplated by the present invention are detailed below. In anotherembodiment of the present invention, an electrical and therapeutic portco-exist to allow direct visualization as the therapy is beingadministered.

To effectively maintain fallopian tubes, the present invention alsooffers non-hydraulically propelled imaging or therapeutic devices. Incertain embodiments of the present invention, a guidewire and/or acatheter, which is positioned over the guidewire, facilitate imaging ortherapy. In other embodiments, the guidewire lumen of the presentinvention facilitates therapeutic intervention.

FIG. 4A shows two different ovular-shaped protective shields, accordingto certain embodiments of the present invention, shown as part of asingle distal tip 326, which may be designed to function either as aguidewire-based diagnostic imaging device or as a guidewire lumen-basedtherapeutic intervention device. FIG. 4B shows a top view of distal tip326′, which is the same as distal tip 326, except in a differentorientation. Two different protective shields, i.e., a first protectiveshield 330 and a second protective shield 330′, are shown in FIG. 4A asbeing part of single distal tip 326, those skilled in the art willrecognize that only one protective shield is necessary in thisembodiment of the present invention.

As shown in FIG. 4A, distal tip 326 of inventive catheters includes ashaft portion 304, one or more light sources 332, an imaging portion 308and a guidewire 334. Guidewire 334 guide inventive catheters during animaging procedure inside the fallopian tubes, for example. According tothe present invention, however, guidewire 334 is preferably designed toprovide light or is capable of sensing an image. To this end, guidewire334 may contain illuminating fibers or imaging fibers. If an inventivecatheter contains illuminating fibers, then the associated guide wire,which guides that catheter during operation, may include imaging fibers.Alternately, if the inventive catheter contains imaging fibers, then theassociated guidewire 334 may include illuminating fibers. According tothe present invention, in this manner, structures for carrying outilluminating and imaging functions may be distributed between a catheterand its associated guidewire. Separating a light source from an imagingsensor allows a device user to control the amount and angle of lightneeded to capture a clearer image (akin to a professional photographerhaving an external flash).

In certain embodiments of the present invention, guidewire 334 includesoptical fibers for providing light to facilitate imaging, and may bemade from fiber optics.

In accordance with one embodiment of the present invention, during anoperation state of device with distal tip 326, guidewire 334 extendsfrom a location outside the fallopian tube to another location insidethe fallopian, such that light is conveyed from the location outside thefallopian tube to the location inside the fallopian tube. Having thesource of the lighting remain outside of the fallopian tube will reduceheat exposure to the fallopian tubes.

In preferred embodiments of the inventive catheters, guidewire 334includes a plurality of substantially transparent portions along alength of the guidewire. Each of the plurality of substantiallytransparent portions allow light to pass through. During an operationalstate of the catheter, each of the substantially transparent portionsilluminate a plurality of different locations along the length of thefallopian tube that are adjacent to the substantially transparentportions. In this embodiment, a light emitting diode (“LED”) may belocated at or around a guidewire's tip and, as a result, incident lightemanating from the LED exits from the substantially transparent portionsand illuminates the tissue.

Inventive catheters may further include an image sensor located at aproximal end of a catheter shaft (e.g., 104 of FIG. 2) or inside ahandle portion (e.g., 102 of FIG. 2) of the catheter. In thisconfiguration of the inventive catheters, the above-mentioned imagingfibers extend along a length of the catheter shaft such that, during anoperational state of the catheter, the imaging fibers facilitate imagingby sending imaging signals from a distal end of the catheter to theimaging sensor. Keeping the sensor outside of the catheter's shaftreduces an outer diameter of the catheter, and therefore, allows thephysician to more easily navigate the fallopian tubes and reduces thepotential for tissue trauma.

In alternate embodiments of the present invention, the catheters furtherinclude an image sensor for sensing an image. In this embodiment, theimage sensor is located at a distal end of a catheter shaft such that,during an operational of the catheter, an image of the fallopian tubesensed by the imaging sensor is conveyed by the imaging fibers or byelectrical wires, which extend along a length of the catheter shaft, toa display unit that is located outside the fallopian tube. Although thisconfiguration may increase the catheter's outer diameter, it provides aclearer image as the sensor is located closer to the image being taken.

Protective shield 330 or 330′ of FIG. 4A, during an operational state ofthe device, preferably protect an image sensor and/or imaging fibers andfurther provide an approximate focal length (that is associated with theimage sensor) between the image sensor and/or the imaging fibers and thefallopian tube to obtain a substantially focused image. Protectiveshield of the present invention overcomes the drawback of the fallopiantube hanging over the catheter's tip, which makes it hard to capture aclear image.

In other preferred embodiments, inventive catheters include a lightsource (e.g., light source 332 shown in FIG. 4A) that is located at adistal end of a catheter shaft such that a substantially transparentprotective shield (e.g., protective shield 330 or 330′ of FIG. 4A)protects the image sensor and/or the imaging fibers, and the lightsource is located outside the protective shield as shown in FIG. 4A.This embodiment prevents illumination of the fallopian tube to bedistorted by the presence of the substantially transparent protectiveshield.

The present invention recognizes that during an imaging operation,fallopian tube tissue might fold over a light source and blockillumination, and thereby, prevent proper illumination of a targetlocation. In alternate preferred embodiments, inventive cathetersinclude a light source that is protected by the substantiallytransparent protective shield. In this embodiment, the presence of aprotective shield, prevents the fallopian tube tissue from folding overand blocking the light source.

To reduce the risk of perforating the fallopian tube during an imagingoperation as encountered by certain imaging attempts discussed above,inventive catheters preferably include a pressure sensor. In oneimplementation of this embodiment, the pressure sensor is located at adistal end of the guidewire and/or the catheter. During an imagingoperation, the pressure sensor is capable of measuring a value ofpressure exerted by the guidewire and/or the catheter against thefallopian tube. The pressure sensor may be communicatively coupled to aprocessor that provides an alert signal during an imaging operation. If,during an imaging operation, the value of pressure exerted by theguidewire and/or the catheter inside the fallopian tube is equal to orexceeds a predetermined unacceptable value of pressure, the pressure mayprovide the alert signal to a catheter's user (e.g., activating a redwarning light on the handle).

Inventive catheters may further include a guidewire lumen having definedtherein a channel for the guidewire (e.g., guidewire 334 of FIG. 4A).During an operational state of the catheter, and in absence of theguidewire inside the guidewire lumen (e.g., when an imaging operationhas concluded), the channel inside the guidewire lumen is capable oftransporting therapy to the fallopian tube.

The therapy includes at least one member selected from a groupconsisting of an anti-inflammatory agent, bio-absorbable stent and adrug-coated inflatable body. In certain embodiments of the presentinvention, a liquid anti-inflammatory agent is delivered locally to adiseased site Inflammation (likely caused by infection) is thought to bethe leading cause of fallopian tube occlusion.

In those embodiments of the present invention where therapy includes abio-absorbable stent, the stent provides to the fallopian tubes bothmechanical support and a drug, which treats a local disease and preventsthe occlusion from recurring. After the stent is absorbed by the bodyand the disease is treated, the egg, may uninterruptedly pass from theovaries through the fallopian tube to the uterus.

With respect to the drug-coated inflatable body, during an operationalstate of the catheter, when the inflatable body (such as a balloon) isexpanded, debris found within the fallopian tube may be dislodged by theforce it takes to expand the balloon. Furthermore, the inflatable bodymay be positioned within a partial blockage. In this case, the expansionforce will applies sufficient mechanical force to a blockage and servesto clear the blockage.

Furthermore, the drug-coating on the inflatable body (e.g.,anti-inflammatory agent) prevents recurrence of those blockages for atime adequate to allow for conception. On the other hand, drug coatedballoons used to treat coronary artery disease, face the challenge of acontinuous blood flow which eventually rids the artery of the drug.Consequently, the patient only temporarily sees the benefit of thetherapy, where treatment of coronary artery disease needs to last alifespan of a patient. In contrast, the fallopian tubes are notinherently fluid filled. Therefore, the drug will last longer in thediseased region of the fallopian tube. Furthermore, the impact of thedrug need only last for as long as it takes the patient to conceive (onaverage 0 to 12 months). If the drug dissipates and blockages do occurat some point after conception, those blockages do not cause any pain ordiscomfort to the patient.

FIG. 5A shows a conical-shaped distal tip 426, according to oneembodiment of the present invention. The conical-shaped distal tip 426is preferably part of a guidewire-based diagnostic imaging device or ina guidewire lumen-based therapeutic intervention device. Regardless ofthe manner in which distal tip 426 is implemented, it includes a shaftportion 404, one or more light sources 432 (labeled in FIG. 5B), animaging portion 408, a protective shield 430 and guidewire 434, all ofwhich are substantially similar to their counterparts shown in FIG. 4A(i.e., shaft portion 304, one or more light sources 332, imaging portion308, protective shield 330 and guidewire 334, respectively), except FIG.5A shows an conical-shaped distal tip provides the image sensor adifferent focal length than that provided by the ovular-shaped distaltip of FIG. 4A, and protective shield 430 has defined therein an ingressaperture 436 and an egress aperture 438. During an imaging operation,guidewire 434, which is positioned outside protective shield 430, iscapable of entering through ingress aperture 436 and exiting from egressaperture 438. In other words, apertures 436 and 438 allow guidewire 434to pass through protective shield 430 and access a location in thefallopian tubes that is distal to protective shield 430. This will allowthe physician to push away from the fallopian tube wall using theguidewire if additional distance is needed in order to capture a clearimage.

Furthermore, the conical shape may introduce less tissue trauma than theovular-shaped protective shield. FIG. 5B is a top view of a distal tip426′, which is the same as distal tip 426 shown in FIG. 5A, exceptdistal tip 426′ has a different orientation than distal tip 426.

Preferred embodiments of the present invention also providenon-guidewire based diagnostic imaging device or a non-guidewirelumen-based therapeutic intervention device. A non-guidewire baseddiagnostic imaging device includes a sensing lumen, a solution lumen andoptionally a therapeutic lumen. The sensing lumen, in turn, includes asensing portion and an inflatable portion. The sensing portion iscapable of sensing information (e.g., imaging information) about thefallopian tube.

The solution lumen is designed to provide a solution, which facilitatessensing carried out by the sensing portion. The solution is alsodesigned to flush the fallopian tube, ridding it of residual blood andmucous, which obscures the image. Furthermore, presence of the solutionfacilitates in the expansion of the fallopian tube and thereby reducesthe chance of causing a perforation. Finally, therapeutic solutions usedin the therapeutic are discussed above in greater detail.

During an operational state of the non-guidewire based diagnosticdevice, the inflatable portion inflates to create a space around thesensing portion such that in presence of the solution, the sensingportion senses information regarding the fallopian tube, including butnot limited to the presence of sterilization implants and naturallyoccurring blockages. This space allows for there to be an adequate focallength between the sensing portion and the fallopian tube wall tofacilitate capturing a clear image (e.g., a clear image may be taken ifthe sensing portion is a standard optical camera or light-wavescattering optical system). However, if the sensing portion consists ofa sound-wave imaging system, then the inflatable portion creates a sealso that the fallopian tube may be filled with a liquid medium, throughwhich sound waves can propagate.

The sensing portion may include at least one member selected from agroup consisting of light source, a camera, an acoustic imaging systemand a scattered-light imaging system. Certain current techniques usedfor cardiovascular imaging (e.g., intravascular ultrasound (“IVUS”) andoptical coherence tomography (“OCT”)) utilize light scattering andacoustic imaging techniques, but do not lend themselves to imagingfallopian tubes because of their rigidity. Furthermore, currentcardiovascular IVUS catheters are not capable of creating a seal tofacilitate imaging of a structure which is inherently non-fluid filledbecause in the absence of a medium, sound waves do not travel. It isnoteworthy that because the fallopian tube is non-fluid filled, a sealmust be created and the fallopian tube must be filled with a liquidmedium, such as saline, before imaging using sound waves can occur.Further still, these catheters have relatively large dimensions whichmake it difficult to access the length of the narrow and tortuousfallopian tube.

To this end, the present invention proposes that catheter designs ofIVUS and OCT may be modified in a manner consistent with the differentrelevant inventive catheters. Inventive catheters described herein arenot limited to IVUS and OCT applications, and work well with otheroptical imaging techniques (e.g., imaging carried out by complementarymetal oxide semiconductor (“CMOS”) or optical fiber). In accordance withpreferred embodiments, inventive catheters include unique atraumatictips and/or inflatable bodies as described below.

The imaging information collected by image portion 508 provides suchinformation about the fallopian tube as naturally occurring blockage,inflammation, hydrosalpinx, sterilization implants operatively placed inthe fallopian tubes and disease of the fallopian tube. This informationis particularly valuable in diagnosing fallopian tube disorder andallows for disease-specific therapeutic intervention, if needed.

FIG. 6A shows a non-guidewire based diagnostic device where the sensingportion senses image information about the fallopian tube, allowing thephysician to diagnose disease. Specifically, FIG. 6A is a side view of anon-inflated conical-shaped distal tip 526, according to one embodimentof the present invention that is preferably used in anon-guidewire-based diagnostic imaging device or in a non-guidewirelumen-based therapeutic intervention device. Distal tip 526 includes animaging portion 508, an inflatable portion 506 and a shaft portion 504.Imaging portion 508 and shaft portion 504 are substantially similar totheir counterparts in FIG. 5A (i.e., imaging portion 408 and shaftportion 404), except shaft portion 404 of FIG. 5A contains a guidewire434.

In accordance with one preferred embodiment, inventive distal tipsinclude a pressure sensor located at a distal end of a catheter and aredesigned to measure a value of pressure exerted by the catheter duringan operational state of the device. The pressure sensor featuresdescribed above to alert a user of undue excessive pressure may also beincorporated in this embodiment.

FIG. 6B is a side view of the conical-shaped distal tip of FIG. 6A inits inflated state. Inflatable portion 506, in its inflated state (i.e.,inflated portion 506′ of FIG. 6B) has an atraumatic shape, which is oneshape selected from a group consisting of conical, ovular and dome.

FIG. 7A is a side view of another non-inflated ovular-shaped distal tip626, according to one embodiment of the present invention, alsopreferably used in a non-guidewire-based diagnostic imaging device or ina non-guidewire lumen-based therapeutic intervention device. Distal tip626 is substantially similar to distal tip 526 of FIG. 6A (i.e., imagingportion 608 and shaft portion 604 are substantially similar to imagingportion 508 and shaft portion 504 of FIG. 6A), except inflatable portion606 of FIG. 7A has a different shape than inflatable portion 506 of FIG.6A. The differences in shape between inflatable portions 506 and 606 areevident in their respective inflatable states and may correspond todifferent focal lengths and different amounts of tissue trauma. FIG. 7Bis a side view of ovular-shaped distal tip 626′, which is in an inflatedstate of distal tip 626 of FIG. 7A.

FIG. 8A is a side view of a non-inflated dome-shaped distal tip 726,according to one embodiment of the present invention, preferably used ina non-guidewire-based diagnostic imaging device or in a non-guidewirelumen-based therapeutic intervention device. Distal tip 726 issubstantially similar to distal tip 526 of FIG. 6A (i.e., imagingportion 708 and shaft portion 704 are substantially similar to imagingportion 508 and shaft portion 504 of FIG. 6A), except inflatable portion706 of FIG. 8A has a different shape than inflatable portion 806 of FIG.6A. Like the differences between inflatable portions 506 and 606, thedifferences in shape among inflatable portions 506, 606 and 706 areevident in their respective inflatable states. FIG. 8B is a side view ofovular-shaped distal tip 726′, which is in an inflated state of distaltip 726 of FIG. 7A.

FIG. 8C shows certain major components, according to one embodiment ofthe present invention, in an inflated distal tip 826, which issubstantially similar to inflated distal tip 726′ of FIG. 8B. FIG. 8Cshows a more detailed structure that is preferably contained withininflatable portion 806. According to this figure, inflatable portion 806includes an inflatable component 806A and a non-inflatable component806B. During an operational state of the device, the inflatablecomponent 806A inflates, while non-inflatable component 806B does notinflate, but serves to provide mechanical support to inflatable portion806.

FIG. 9 shows a process flow diagram 900, according to one embodiment ofthe present invention that uses a hydraulic propulsion mechanism fordiagnostic imaging. Preferably process 900 begins in step 902, whichinvolves establishing a channel from outside a narrow body lumen to aproximal region of the narrow body lumen or a region that is proximateto the narrow body lumen. By way of example, a hysteroscope is used tovisualize and gain access to the ostia of the fallopian tubes withinuterus. In this case, the working channel of the hysteroscopeestablishes the channel of step 902 from outside the fallopian tube tothe ostia of the fallopian tube within uterus.

Next, step 904 of FIG. 9 includes placing an imaging device or atherapeutic device through the channel. Continuing with the aboveexample of the hysteroscope, step 904 is carried out by introducingshaft portion 104 of device 100 of FIG. 2 through the working channel ofthe hysteroscope until the distal end of shaft portion 104 is slightlydistal to the distal end of the hysteroscope's working channel or untilthe distal end of shaft portion 104 is located in the approximate regionof the fallopian tube.

In this configuration, step 906 of FIG. 9 is carried out. Step 906includes creating a seal in or outside the narrow body lumen such thatin presence of a hydraulic propellant the narrow body lumen ispressurized to allow diagnostic imaging or therapeutic treatment of thenarrow body lumen. In order to create a seal in the fallopian tube, forexample, the seal-creating portion 106 of FIG. 2 may be expanded eitherproximal to the fallopian tube ostia in the uterus or within theproximal region of the fallopian tube. The seal will allow pressure tobuild the portion of the device which is meant to be hydraulicallypropelled.

Then, another step 908 of FIG. 9 includes hydraulically propelling,using the hydraulic propellant, the imaging portion (108 of FIG. 2A) orthe therapeutic device contained in the capsule (110 of FIG. 2A) throughthe narrow body lumen. By way of example, device 200 of FIG. 3 shows acapsule 210, which is attached to handle portion 102 of FIG. 2 by a wire218 of FIG. 3, being hydraulically propelled. Several steps may be takento aid in the propulsion of the capsule (e.g., capsule 210 of FIG. 3).The capsule, which may be made from a substantially transparentmaterial, is preferably inflated. Alternately, the capsule may containan inflatable body, such as a balloon, which is preferably inflated.These steps enhance the buoyancy of the capsule, aiding the propulsionof the capsule. Furthermore, in its propelled state, sails 238 of FIG. 3attached to imaging subassembly 208 will deploy to capture the hydraulicpropellant (which is akin to sails on a sail boat that capture the powerof wind to propel the boat's forward movement).

After step 908 and once a diseased portion of the fallopian tube or thefimbria of the fallopian tube is reached, step 910 of FIG. 9 includestreating or imaging the narrow body lumen. As discussed above inreference to FIGS. 2, 2A, 2B and 3 imaging is carried out by imagingsubassembly 108 of FIG. 2A. Imaging, according to certain embodiments ofinventive step 908, is carried out in an antegrade fashion (duringforward propulsion of imaging subassembly 108) or retrograde fashion(during retrieval of imaging subassembly 108). With respect to treatingthe narrow body lumen, once the disease state is imaged, one therapyselected from a group consisting of flushing saline to rid the fallopiantube of debris, applying anti-inflammatory agent in liquid form andapplying mechanical force to an occlusion using an inflatable body(e.g., seal-creating portion 104 of FIG. 2), is preferably carried out.

Process 900 preferably comes to an end in step 912 of FIG. 9, whichinvolves retrieving the imaging device from the narrow body lumen. Byway of example, retrieval mechanism 122 of FIG. 2 is activated toretrieve the imaging device from the fallopian tube. The retrievalmechanism is preferably activated by engaging a reel mechanism (e.g.,mechanism 122 of FIG. 2), which is placed on the handle. Alternately,the entire device may be pulled back towards the user to remove it fromthe narrow body lumen.

It is noteworthy that steps 902 and 904 of FIG. 9 are optional and thatthe steps mentioned above need not be carried out in any particularorder. Rather the sequence of steps described above represent a morepreferred embodiment of the present invention. Process 900 can becarried out using any structure and is not limited to any structureshown in FIGS. 2, 2A, 2B and 3. The structures shown in these figuresserve as examples and are used to facilitate discussion regardingprocess 900.

FIG. 10 shows a process flow diagram 1000, according to one embodimentof the present invention that uses a guidewire mechanism for diagnosticimaging. Preferably process 1000 begins in step 1002, which involvesestablishing a channel from outside a female anatomy to a proximalregion of a fallopian tube or a fallopian tube ostia within uterus. Step1002 is substantially similar to the imaging aspect of step 902 of FIG.9.

Next, step 1004 includes steering a guidewire through the channel to atarget location within a lumen of a fallopian tube and the guidewirecapable of providing light or imaging. By way of example, guidewire 334in FIG. 4A is bundle of optical fiber capable of providing light orimaging a fallopian tube.

In this configuration, step 1006 is carried out. Step 1006 includesplacing a catheter, which facilitates imaging or therapy, over the guidewire. Depending on whether guidewire 334 of FIG. 4A is capable ofimaging or illuminating, the catheter contains the complementarystructure to facilitate imaging.

Then, another step 1008 includes imaging the fallopian tube using theguidewire and the catheter. By way of example, imaging as required bythis step is carried out by positioning guidewire 334 of FIG. 4Arelative to the catheter (e.g., catheter 304 of FIG. 4A) so that thecorrect amount and angle of light illuminates the portion of fallopiantube being imaged. Furthermore, a protective shield (e.g., shield 330 ofFIG. 4A) is positioned so that the appropriate focal length is achievedbetween the fallopian tube wall and the imaging portion (e.g., imagingportion 308 of FIG. 4A).

After step 1008, step 1010 includes removing the guidewire from thechannel. Continuing with the guidewire example of FIG. 4A, guidewire 344is removed from the hysteroscope's working channel referenced in step1002 of FIG. 10. This allows the guidewire channel to be used fordelivery of therapy.

Next step 1012 includes introducing regional therapy to the fallopiantube through the channel. Therapy in this step is preferably introducedby way of an additional therapeutic catheter or in liquid form throughthe guidewire channel discussed above.

Process 1000 preferably comes to an end in step 1014, which involvestreating the fallopian tube using the regional therapy or the catheter.Therapy in this step is preferably one therapeutic solution selectedfrom a group consisting of applying an anti-inflammatory agent in liquidform, introducing a drug-coated balloon (e.g., coated with ananti-inflammatory), introducing a bio-absorbable stent and flushing withsaline to remove debris from the fallopian tube.

It is noteworthy that steps 1002. 1010, 1012 and 1014 are optional andthat the steps mentioned above need not be carried out in any particularorder. Rather the sequence of steps described above represent a morepreferred embodiment of the present invention. In one preferredembodiment of the present invention, another step may be added.Specifically, after imaging has concluded at the end of step 1008,another step, which includes retrieving the catheter from the fallopiantube is more preferably carried out. Process 900 can be carried outusing any structure and is not limited to any structure shown in FIGS.4A, 4B, 5A and 5B. The structures shown in these figures serve asexamples and are used to facilitate discussion regarding process 1000.

Although illustrative embodiments of this invention have been shown anddescribed, other modifications, changes, and substitutions are intended.By way of example, the present invention discloses fallopian tubes as anexemplar of a narrow body lumen, which may undergo maintenance, andother anatomical structures, such as coronary arteries, may be similarlymaintained Accordingly, it is appropriate that the appended claims beconstrued broadly and in a manner consistent with the scope of thedisclosure, as set forth in the following claims.

1. A narrow body lumen diagnostic device, comprising: a guide wirecapable of providing light or sensing an image and for guiding acatheter to a target location, said guide wire including illuminatingfibers or imaging fibers; and a catheter including imaging fibers ifsaid guide wire includes illuminating fibers or said catheter includingilluminating fibers if said guide wire includes imaging fibers.
 2. Thedevice of claim 1, wherein said guide wire includes optical fibers forproviding light.
 3. The device of claim 1, wherein during an operationstate of said device, said guide wire extends from a location outsidesaid narrow body lumen to another location inside narrow body lumen,such that light is conveyed from said location outside said narrow bodylumen to said another location inside said narrow body lumen.
 4. Thedevice of claim 1, wherein said guide wire includes a plurality ofsubstantially transparent portions along said length of said guide wire,and each of said plurality of substantially transparent portions allowslight to pass through and, during an operational state of said device,illuminate a plurality of different locations along said narrow bodylumen that are adjacent to said plurality of substantially transparentportions.
 5. The device of claim 1, further comprising an image sensorlocated at a proximal end of a catheter shaft or inside a handle portionof said catheter, and wherein said imaging fibers extend along a lengthof said catheter shaft such that, during an operational state of saiddevice, said imaging fibers facilitate imaging by sending imagingsignals from a distal end of said catheter to said imaging sensor. 6.The device of claim 1, further comprising an image sensor for sensing animage, and wherein said imaging sensor is located at a distal end of acatheter shaft such that, during an operational of said device, an imageof said narrow body lumen sensed by said imaging sensor is conveyed bysaid imaging fibers, which extend along a length of said catheter shaft,to a display unit that is located outside said narrow body lumen.
 7. Thedevice of claim 1, further comprising a substantially transparentprotective shield that, during an operational state of said device,protects an image sensor or said imaging fibers and that provides anapproximate focal length between said image sensor or said imagingfibers and said narrow body lumen to obtain a substantially focusedimage of said narrow body lumen, and said focal length is associatedwith said image sensor or said imaging fibers.
 8. The device of claim 7,wherein said guide wire is located outside said substantiallytransparent protective shield, which has defined therein an ingressaperture and an egress aperture, such that during said operational stateof said device, said guide wire is capable of passing through saidingress aperture and said egress aperture to allow said guide wire toaccess a portion of said narrow body lumen that is located distal tosaid protective shield.
 9. The device of claim 7, further comprising alight source that is located at a distal end of a catheter shaft, andwherein said substantially transparent protective shield protects saidimage sensor or said imaging fibers, and a said light source is locatedoutside said protective shield.
 10. The device of claim 7, furthercomprising a light source that is protected by said substantiallytransparent protective shield.
 11. The device of claim 1, furthercomprising a pressure sensor that is located at a distal end of saidguide wire or said catheter and during an operational state of saiddevice, said pressure sensor capable of measuring a value of pressureexerted by said guide wire or said catheter.
 12. The device of claim 11,wherein said pressure sensor is communicatively coupled to a processorthat provides an alert signal during said operational state of saiddevice when said value of pressure exerted by said guide wire or saidcatheter inside said narrow body lumen is equal to or exceeds apredetermined unacceptable value of pressure.
 13. The device of claim 1,further comprising a guide wire lumen having defined therein a channelfor housing said guide wire, such that during an operational state ofsaid device and in absence of said guide wire inside said guide wirelumen, said guide wire lumen is capable of transporting therapy to saidnarrow body lumen.
 14. The device of claim 13, wherein said therapy isat least one member selected from a group consisting of ananti-inflammatory agent, bio-absorbable stent and a drug-coatedinflatable body.
 15. The device of claim 14, wherein during saidoperational state of said device, said inflatable body is capable ofapplying sufficient mechanical force to a blockage of said narrow bodylumen to dislodge debris blocking portions of said narrow body lumen.16. A narrow body lumen diagnostic device, comprising: a guide wirecapable of providing light or sensing an image and for guiding acatheter to a target location, the guide wire including illuminatingfibers and a plurality of substantially transparent portions along alength of the guide wire, the plurality of substantially transparentportions allowing light to pass through and, during an operational stateof the device, illuminate a plurality of different locations along thenarrow body lumen that are adjacent to the plurality of substantiallytransparent portions; and a catheter including imaging fibers.
 17. Thedevice of claim 16, wherein during an operation state of said device,said guide wire extends from a location outside said narrow body lumento another location inside narrow body lumen, such that light isconveyed from said location outside said narrow body lumen to saidanother location inside said narrow body lumen.
 18. The device of claim16, further comprising a pressure sensor that is located at a distal endof said guide wire or said catheter and during an operational state ofsaid device, said pressure sensor capable of measuring a value ofpressure exerted by said guide wire or said catheter.
 19. The device ofclaim 16, further comprising a guide wire lumen having defined therein achannel for housing said guide wire, such that during an operationalstate of said device and in absence of said guide wire inside said guidewire lumen, said guide wire lumen is capable of transporting therapy tosaid narrow body lumen.
 20. A narrow body lumen diagnostic device,comprising: a guide wire capable of providing light for guiding acatheter to a target location, the guide wire including illuminatingfibers; a catheter including a catheter shaft and imaging fibers; and animage sensor located at a proximal end of the catheter, wherein theimaging fibers extend along a length of the catheter shaft such that,during an operational state of the device, the imaging fibers facilitateimaging by sending imaging signals from a distal end of the catheter tothe imaging sensor at the proximal end of the catheter.